510(k) K192322

T-Stat 2.0 Microvascular Tissue Oximeter by Spectros Corporation — Product Code MUD

K192322 is an FDA 510(k) premarket notification submitted by Spectros Corporation for the device "T-Stat 2.0 Microvascular Tissue Oximeter". The FDA issued a decision of Substantially Equivalent on September 23, 2019. The device falls under product code MUD (Oximeter, Tissue Saturation), a Class II device regulated under 21 CFR 870.2700. Spectros Corporation has at least 2 other 510(k) clearances on record.